A Study to assess the Effect and Safety of Tacrolimus Lipid Tablets Compared to Tacrolimus simple Tablets in Adult Patients with Rheumatoid Arthritis Who are not responding to conventional medications

Phase 2

Completed

• Conditions: Health Condition 1: M069- Rheumatoid arthritis, unspecified

• Registration Number: CTRI/2015/09/006201
• Lead Sponsor: Intas Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-11-16
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 102

Inclusion Criteria

1. Patient willing to give written, signed and dated informed consent to participate in the study before initiating any study related procedures

2. Adult patients of age 18 years or older who should meet the criteria for Rheumatoid Arthritis as per American College of Rheumatology at least for last 6 months with ACR functional class Iâ??III

3. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, emale condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during tudy and up to 30 days after the last dose of study drug

4. In case of Male patients: Either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug

5. No other serious illness that according to investigator might jeopardize the well-being, the safety of patients, the compliance to study medications and validity of data generated during the study.

Exclusion Criteria

1. Known hypersensitivity to Tacrolimus or any of its components

2. Patients who had received biological products with an inhibitory effect on the progression of joint destruction (e.g. Infliximab, etanercept) within 12 weeks before administration of the study drug

3. Patients who had previously received Tacrolimus for current disease

4. Pregnant or breast-feeding female

5. Clinically significant Liver disease (defined by levels of Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, or Total bilirubin >=2 times the upper limit of normal)

6. Clinically significant renal disease (defined by serum creatinine (Cr) >=2 times the upper limit of normal)

7. Clinically significant Bone marrow suppression defined as haemoglobin level <9 gm/dl, white blood cell count < 3,000/mm3, platelet count <100,000/mm3

8. Patients with Hepatitis B or C infection

9. Have active dysphagia, swallowing disorders, bowel obstruction, or severe gastrointestinal motility disorders.

10. Have any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion

11. Have participated in a study of an investigational drug during the 30 days preceding randomization

Study & Design

• Study Type: Interventional
• Study Design: Not specified